Skip to main content
RecallsAboutBlog

Instrumentation Laboratory

Instrumentation Laboratory: 5 recalls listed since January 2026 across FDA; 1 rated high risk.

By year

  • 20265

By agency

  • FDA5

By category

  • Medical Device5

All recalls (5)

Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4)

The HemoslL AcuStar HIT-lgG(PF-4) may have an invalid calibration curve or negative mean bias with patient samples.

High risk, FDA, , Device defect

Instrumentation Laboratory GEM Premier 7000 and GEM Premier 5000 Blood Analyzers

The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 and GEM Premier 5000 PAK lots did not meet established manufacturing specifications.

Moderate risk, FDA, , Device defect

Instrumentation Laboratory GEM Premier 5000 and GEM Premier 7000 Blood Analyzers

GEM Premier 5000 and 7000 systems with BCR wands may assign results to wrong patient.

Moderate risk, FDA, , Device defect

GEM Premier 5000

GEM Premier 5000 PAK may experience increased Process Control Solution Not Detected errors during warm-up, causing ejection and delays.

Moderate risk, FDA, , Device defect

Instrumentation Laboratory Coagulation Testing Reagents

The product has potential for microbial contamination.

Moderate risk, FDA, , Contamination
Embed this list